Surgery With or Without Chemotherapy in Treating Patients With Stage I Non-small Cell Lung Cancer

Phase 3

Completed

• Conditions: Adenocarcinoma of the Lung; Adenosquamous Cell Lung Cancer; Bronchoalveolar Cell Lung Cancer; Large Cell Lung Cancer; Squamous Cell Lung Cancer; Stage IB Non-small Cell Lung Cancer
• Interventions: Drug: paclitaxel; Drug: carboplatin; Procedure: therapeutic conventional surgery

• Registration Number: NCT00002852
• Lead Sponsor: National Cancer Institute (NCI)

Brief Summary

Randomized phase III trial to compare the effectiveness of surgery with or without combination chemotherapy in treating patients who have stage I non-small cell lung cancer. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. It is not yet known whether surgery is more effective with or without chemotherapy for non-small cell lung cancer.

Detailed Description

PRIMARY OBJECTIVES:

I. To determine if adjuvant chemotherapy can favorably alter the prognosis of the subgroup of resected stage I patients who, following complete surgical resection of their disease, are defined as "high risk" based on the presence of a T2N0 tumor (according to the criteria of the International Staging System for lung cancer).

SECONDARY OBJECTIVES:

I To compare failure-free survival of patients with T2N0 stage I NSCLC who have and have not been treated with adjuvant chemotherapy.

II. To determine the toxicities associated with adjuvant chemotherapy. III. To describe the pattern of disease recurrence.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to tumor histology (squamous cell vs nonsquamous cell), degree of differentiation (poorly differentiated vs other), and mediastinal node sampling at surgery (yes vs no). Within 4-8 weeks after surgery, patients are randomized to 1 of 2 treatment arms.

Arm I:Patients receive no further therapy.

Arm II: Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.

Patients are followed every 4 months for 2 years and then every 6 months thereafter.

Study Timeline

• Study Start: 1996-10
• Study First Submitted: 1999-11-01
• Study First Submitted QC: 2003-01-26
• Study First Posted: 2003-01-27
• Primary Completion: 2004-07
• Status Verified: 2013-07
• Last Update Submitted: 2013-07-02
• Last Update Posted: 2013-07-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

• Histologically documented non-small cell carcinoma
• Completely resected T2N0M0 Stage I NSCLC as defined by the International Staging System
• Surgery shall consist of a lobectomy or pneumonectomy with resection of associated N1 lymph nodes (either by thoracotomy or thoracoscopy)
• Patients must be randomized within 4 to 8 weeks from the date of complete surgical resection
• No prior chemotherapy or radiation for non-small cell lung cancer
• Performance status of 0 or 1
• Women must be non-pregnant and non-lactating; patients of childbearing potential must agree to use an effective form of contraception while on study
• Patients must have no history of previous or concomitant malignancy, other than curatively treated carcinoma in situ of the cervix, or basal cell or squamous cell carcinoma of the skin, or surgically treated in situ carcinoma of the breast, or other cancer for which the patient has bee disease free for five years
• Granulocytes >= 1,800/ul
• Platelets >= 100,000/ul
• Bilirubin < 1.5 mg/dl
• SGOT (AST) < 2.0 x ULN

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II (surgery, chemotherapy)	therapeutic conventional surgery	Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.
Arm I (surgery, observation)	therapeutic conventional surgery	Patients receive no further therapy.
Arm II (surgery, chemotherapy)	carboplatin	Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.
Arm II (surgery, chemotherapy)	paclitaxel	Patients receive adjuvant therapy comprising paclitaxel IV over 3 hours followed by carboplatin IV over 1-2 hours on day 1. Treatment continues every 3 weeks for 4 courses.

Primary Outcome Measures

Name	Time	Method
Overall survival (OS)	Up to 2.4 years	OS curves will be calculated using the Kaplan-Meier life-table method. Comparison of the survival curve for the two treatment regimens will be performed using the log-rank test for censored data.
Failure-free survival	Time between randomization and disease relapse or death, assessed up to 2.4 years	Failure-free survival curves will be calculated using the Kaplan-Meier life-table method.

Secondary Outcome Measures

Name	Time	Method
Toxicity as assessed by Common Toxicity Criteria version 2.0	Up to 1 year after completion of treatment
Pattern of disease recurrence.	Up to 2 years	The frequency of local and distant relapse and the incidence of a second primary lung cancer will be tabulated by treatment.

Trial Locations

Locations (1)

Cancer and Leukemia Group B; 🇺🇸 Chicago, Illinois, United States